The LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

Device Description

The LensHooke CA0 Sperm Separation Device and LensHooke CA1 Sperm Separation Device are used to prepare motile sperm from semen based on the mobility of motile sperm. The LensHooke Sperm Separation Device has a base and filter layers to separate and process the semen sample. The LensHooke Sperm Separation Device has two models, CA0 with one filter layer and CA1 with two filter layers. Liquefied semen (1 mL) is added to the base and sperm washing medium is added to the filter via a filter port. After incubation, the separated sperm are collected from the filter layer via the filter port. The subject devices are radiation-sterilized with a sterility assurance level (SAL) of 10 °. The LensHooke Sperm Separation Devices are individually packaged and for single-use only.

AI/ML Overview

The device in question is the LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device.

Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Human Sperm Survival Assay (HSSA): ≥80% of the control motility at 24 hours after exposure for 30 minutes.	The HSSA was performed before and after accelerated aging to support a 2-year shelf life. The rate of motile sperm after incubation was compared to that of a control (no exposure to the subject device). The device met this criterion.
Endotoxin: ≤20 EU/device	The device demonstrated levels of endotoxin below or equal to 20 EU/device, as confirmed by USP<85> and ANSI/AAMI ST72:2019 testing.
Sterility: 10⁻⁶ SAL (Sterility Assurance Level)	The device underwent Sterilization Validation Study per ISO 11137-1:2006, confirming a sterility assurance level of 10⁻⁶.
Package Integrity (Seal Strength): Met requirements of ASTM F88/F88M-15	Package integrity testing following accelerated aging per ASTM F1980-21 included Seal strength testing Per ASTM F88/F88M-15. The device met this criterion.
Package Integrity (Dye Penetration): Met requirements of ASTM F1929-15	Package integrity testing following accelerated aging per ASTM F1980-21 included Dye penetration testing per ASTM F1929-15. The device met this criterion.
Transportation Simulation: Met requirements of ISTA 3A (2018)	A Transportation Simulation Study per ISTA 3A (2018) was conducted to ensure the device's integrity during transport. The device met this criterion.
Sperm Separation Performance (Motility Improvement): Improvement in percentage of motile sperm and progressively motile sperm in output samples compared to input samples.	CA0 device: Average improvement in total motility of 24.4% and an average improvement in progressive motility of 26.6%. CA1 device: Average improvement in total motility of 25.9% and an average improvement in progressive motility of 27.1%. Note: Specific quantitative acceptance criteria for motility improvement were not explicitly stated in the provided text, but the reported improvements demonstrate effective performance.
Shelf-Life: 24 months	Supported by package integrity and HSSA testing after accelerated aging.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample size for the "test set" in terms of number of donor semen samples used for the Human Sperm Survival Assay (HSSA) or the Sperm Separation Performance study. It mentions using "donor sperm" and "donor semen samples" without specifying the quantity.

Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The studies described are primarily benchtop or laboratory performance tests, not clinical studies involving expert interpretation of results to establish ground truth in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are technical performance tests and not clinical studies requiring expert adjudication of case interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The studies described are focused on the device's technical performance in isolating motile sperm and maintaining sperm viability, not on comparing reader effectiveness with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, the studies described are standalone performance evaluations of the device (LensHooke CA0/CA1 Sperm Separation Device) without human-in-the-loop performance considerations. The device is a physical product designed for sperm separation, not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth for the performance studies was established through:

Laboratory measurements and assays: For HSSA, this involves measuring sperm motility percentage using established laboratory methods. For endotoxin, it's quantitative measurement against a standard. For sterility, it's confirmation of a specific SAL.
Comparison to control samples: In the HSSA, the motility of sperm exposed to the device was compared to that of a control group (sperm not exposed to the device).
Direct measurement of output characteristics: For sperm separation performance, the percentage of motile and progressively motile sperm in the output samples was directly measured and compared to the input samples.
Industry standards and specifications: For physical tests like package integrity and transportation simulation, the ground truth is adherence to the specified ASTM and ISTA standards.

8. The Sample Size for the Training Set:

This information is not applicable. The LensHooke CA0/CA1 Sperm Separation Device is a physical medical device, not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as the device is not an AI/machine learning algorithm requiring a training set.

Summary

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October 31, 2022

Bonraybio Co., LTD. % Feng-Yu Lee Principal Regulatory Consultant IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212 San Juan Capistrano, CA 92675

Re: K221810

Trade/Device Name: LensHooke CA0 Sperm Separation Device LensHooke CA1 Sperm Separation Device Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: September 28, 2022 Received: September 29, 2022

Dear Feng-Yu Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221810

Device Name

LensHooke CA0 Sperm Separation Device LensHooke CA1 Sperm Separation Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K221810 Page 1 of 4

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510(K) Summary K221810

Submitter/Correspondent: 1

1.1 Submitter:
BonrayBio Co., Ltd. 4F., No.118, Gongye 9th Rd., Dali Dist., Taichung City 41280, Taiwan Contact Person: Clare Huang TEL: +886-4-24912385 FAX: +886-4-24912885
1.2 Submission Correspondent:
IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212, San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee TEL: 1-949-218-0929 FAX: 1-949-218-0928
1.3 Date Summary Prepared: October 27, 2022

2 Subject Device:

Proprietary Name:	LensHooke CA0 Sperm Separation DeviceLensHooke CA1 Sperm Separation Device
Common Name:	Sperm Separation Device
Regulation Name:	Assisted Reproduction Labware
Regulation Number:	884.6160
Product Code:	MQK
Regulatory Class:	II

3 Predicate Device:

ZyMōt Multi Sperm Separation Device (850µl, 3 mL) Device Company: DxNow, Inc. 510(k) Number: K173075

The predicate device has not been subject to a design-related recall.

4 Device Description

The LensHooke CA0 Sperm Separation Device and LensHooke CA1 Sperm Separation Device are used to prepare motile sperm from semen based on the mobility of motile sperm.

The LensHooke Sperm Separation Device has a base and filter layers to separate and process

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Image /page/4/Picture/1 description: The image contains the logo for "bonraybio". The logo consists of a circular icon on the left and the company name on the right. The icon features a stylized plant or leaf design in a light blue color, enclosed within a circle of the same color. The company name, "bonraybio", is written in a sans-serif font in a dark gray color.

the semen sample. The LensHooke Sperm Separation Device has two models, CA0 with one filter layer and CA1 with two filter layers. Liquefied semen (1 mL) is added to the base and sperm washing medium is added to the filter via a filter port. After incubation, the separated sperm are collected from the filter layer via the filter port.

The subject devices are radiation-sterilized with a sterility assurance level (SAL) of 10 °. The LensHooke Sperm Separation Devices are individually packaged and for single-use only.

5 Indications for Use

6 Comparison of Intended Use and Technological Characteristics with the Predicate Device:

	LensHooke® CA0 and CA1Sperm Separation Device(Subject Device)	ZyMōt Multi Sperm Separation Device(850 µL, 3 mL)(Predicate Device - K173075)
Indications for Use	The LensHooke CA0 Sperm Separation Deviceand the LensHooke CA1 Sperm SeparationDevice are intended for preparing motilesperm from semen for use in the treatmentof infertile couples by intracytoplasmic sperminjection (ICSI), in vitro fertilization (IVF) andintrauterine insemination (IUI) procedures.	The ZyMōt Multi Sperm SeparationDevice is intended for preparing motilesperm from semen for use in thetreatment of infertile couples byintracytoplasmic sperm injection (ICSI),in vitro fertilization (IVF) andintrauterine insemination (IUI)procedures.
Design	A disposable device containing a base, filterlayer(s), and a port on the filter for medialoading and sperm collection afterprocessing.- CA0 with one filer layer- CA1 with two filter layers	ZyMōt Multi – A disposable culturedish containing a separation chamberand an inlet port. The separationchamber has a lower sample chamberand an upper collection chamber. Thetwo chambers are separated by amicroporous filter.
Mechanism ofaction	Liquefied semen is added to the base. Thefilter(s) are placed on the base andseparation medium added through the layerport.The loaded device is incubated at 37°C for30 minutes to allow motile sperm to swim upand across the filter(s) to migrate into theseparation medium in the upper filter layer.	ZyMōt Multi - The semen is added tothe inlet port to fill the lower samplechamber; then, the separationmedium is added to the uppercollection chamber.The loaded device is incubated at 37°Cfor 30 minutes to allow motile spermto swim up and cross the filter tomigrate into the over-layingseparation medium in the uppercollection chamber

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Material	Polycarbonate	Polymethylmethacrylate, polycarbonate, flash-spun high-density polyethylene fibers
Human SpermSurvival Testing	≥80% of the control motility at 24 hours after exposure for 30 minutes	≥80% of the control motility at 24 hours after exposure for 30 minutes
Endotoxin	≤20 EU/device	≤2.5 EU/device
Sterile	Yes	Yes
Shelf-Life	24 months	12 months

The subject and predicate devices have the same indications for use and intended use. The subject device and predicate device have the same fundamental design incorporating a chamber for loading semen, a filter for motile sperm to migrate through, and a port for collection of motile sperm. However, there are technological differences between the subject and predicate devices, including the number of filters, materials, endotoxin specifications, and shelf-life duration). These differences do not raise different questions of safety and effectiveness.

7 Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows :

The following testing has been performed on the LensHooke CAO and CA1 Sperm Separation Devices:

Sterilization Validation Study per ISO 11137-1:2006
Transportation Simulation Study per ISTA 3A (2018)
Package integrity testing following accelerated aging per ASTM F1980-21 to support a 2-year shelf-life:
- o Dye penetration testing per ASTM F1929-15
- Seal strength testing Per ASTM F88/F88M-15 O
Endotoxin testing per USP<85> and ANSI/AAMI ST72:2019: <20 EU/device ●
Human Sperm Survival Assay (HSSA) before and after accelerated aging to support a 2-year shelf life:
- Donor sperm were exposed to the subject devices for 30 minutes and then, O incubated at room temperature for 24 hours. The rate of motile sperm after incubation was compared to that of the control (no exposure to the subject device). The acceptance criterion is ≥80% of the control motility at 24 hours after exposure for 30 minutes
Sperm Separation Performance: ●
- Each version of the subject device was used to separate motile sperm from O donor semen samples. The separation procedures followed the Instructions for Use, and the percentage of motile sperm and progressively motile sperm in the output samples were compared to those of the input samples. The results showed an average improvement in total motility of 24.4% and 25.9% for the CA0 and CA1 devices, respectively. The results showed an average improvement in progressive motility of 26.6% and 27.1% for the CA0 and CA1 devices, respectively.

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8 Conclusions

The subject and predicate devices have the same intended use and comparable technological characteristics. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.

Regulation Number and Section

§ 884.6160 Assisted reproduction labware.

(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.